CN115363828A

CN115363828A - Operating handle of heart implant, implanting instrument and operating method

Info

Publication number: CN115363828A
Application number: CN202211298560.0A
Authority: CN
Inventors: 阙诗昊; 郑卜纵; 王建兵; 徐军
Original assignee: Suzhou Huihe Medical Technology Co ltd; Shanghai Huihe Healthcare Technology Co Ltd
Current assignee: Suzhou Huihe Medical Technology Co ltd; Shanghai Huihe Healthcare Technology Co Ltd
Priority date: 2022-10-24
Filing date: 2022-10-24
Publication date: 2022-11-22
Anticipated expiration: 2042-10-24
Also published as: CN115363828B

Abstract

The invention discloses an operating handle of a heart implant, an implanting instrument and an operating method. The operating handle comprises a stroke seat, a middle pipe connecting seat and an inner pipe connecting assembly, wherein an interlocking and dissociating mechanism is arranged between the inner pipe connecting assembly and the stroke seat; when the interlocking and disconnecting mechanism is in a first locking state, the rear end part of the stroke seat is connected with the inner pipe connecting assembly and locked by the interlocking and disconnecting mechanism, and the middle pipe connecting seat can move in a first stroke; in a second locking state, the rear end part of the stroke seat is connected with the inner pipe connecting assembly and locked by the interlocking and disconnecting mechanism, and the middle pipe connecting seat can move in a second stroke behind the first stroke; in the disconnected state, the inner pipe connecting component is released to move backwards along the central line relative to the stroke seat and the middle pipe connecting seat. The invention can prevent misoperation and ensure that the inner tube of the delivery sheath tube used for the front clamp assembly is allowed to release the heart implant after the middle tube of the delivery sheath tube performs the action on the front clamp assembly.

Description

Operating handle of heart implant, implanting instrument and operating method

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an operating handle of a cardiac implant, an implantation instrument and an operating method.

Background

Structural heart disease refers to the anatomical change of blood vessels and the physiological change of cases caused by the change of the internal tissues of the heart and the blood vessels generated by the internal tissues of the heart due to anatomical abnormality, and comprises congenital, valvular heart disease, cardiomyopathy and macrovascular disease. For example, for the treatment of mitral regurgitation, there are many products currently on the market that treat mitral regurgitation in a manner of edge-to-edge repair.

An implantation instrument for an implant for mitral regurgitation generally comprises: the operation handle and the conveying sheath tube. The function of the delivery sheath is to deliver the implant to the mitral valve of the left atrium through the heart vessel, and the implant is controlled to clamp the mitral valve and release the implant after being closed through a plurality of series of movement logic combinations such as sequential movement of a plurality of layers of sheaths. A typical implant includes an anterior clamp assembly and a posterior clamp assembly, and the delivery sheath is required to perform a series of actions of opening, then closing, and the anterior and posterior clamp assemblies, respectively. The operation handle is responsible for controlling the conveying sheath to execute the actions according to the correct logic sequence. The operation is complex, the operation logic has higher requirements, and misoperation is easy to occur in the operation, thereby bringing danger to patients. For example, releasing the implant before performing the act of minimizing the closure of the anterior clamp assembly can have serious consequences such as dislodgement of the implant from the heart valve.

Disclosure of Invention

In view of the above problems, it is an object of the present invention to provide an operating handle for a cardiac implant, an implantation instrument and an operating method, which prevent erroneous operation, in which the front clamp assembly must be closed to a minimum before the inner tube releases the cardiac implant.

According to an aspect of the present invention, an operating handle of a cardiac implant for manipulating a delivery sheath so that the implant clamps cardiac tissue includes a housing, and an outer tube connecting seat, a middle tube connecting seat and an inner tube connecting assembly respectively connected to an outer tube, a middle tube and an inner tube of the delivery sheath, the housing having a center line extending along a length direction of the delivery sheath;

the operating handle also comprises a stroke seat positioned behind the outer pipe connecting seat, the stroke seat can be movably connected with the shell along the central line, the middle pipe connecting seat can be movably arranged on the stroke seat along the central line, and an interlocking and dissociation mechanism is arranged between the inner pipe connecting assembly and the stroke seat;

the interlocking and disconnecting mechanism is provided with a first locking state and a disconnecting state, and when the interlocking and disconnecting mechanism is in the first locking state, the rear end part of the stroke seat is connected with the inner pipe connecting assembly and is locked by the interlocking and disconnecting mechanism; in the disengaged state, the inner tube connection assembly is released to be able to move rearward along the centerline relative to the travel seat and the middle tube connection seat.

Preferably, the interlock and release mechanism has a second locking state, and in the first locking state, the middle pipe connecting seat can move in a first stroke; in the second locked state, the rear end portion of the stroke seat is connected to the inner pipe connecting assembly and locked by the interlock and release mechanism, and the middle pipe connecting seat is movable in a second stroke located on the rear side of the first stroke.

More preferably, the interlocking and disconnecting mechanism comprises a first locking member, and when the interlocking and disconnecting mechanism is in the first locking state, the first locking member is positioned behind the stroke seat or is abutted against the stroke seat; when the interlocking and disconnecting mechanism is in the second locking state and the disconnecting state, the first locking piece is far away from the rear part of the stroke seat.

More preferably, the first locking member is a bolt, the inner pipe connecting assembly is provided with a bolt hole into which the bolt can be inserted, and the middle pipe connecting base is further provided with a limiting part used for being matched with the bolt; when the interlocking and disconnecting mechanism is in the first locking state, the front end part of the inner pipe connecting assembly is sleeved on the rear end part of the stroke seat, the bolt is inserted into the bolt hole, and the limiting part is positioned in front of the bolt or is abutted against the bolt; when the interlocking and releasing mechanism is in the second locking state and the releasing state, the bolt is separated from the bolt hole.

Furthermore, the middle pipe connecting seat is also provided with a connecting part, the inner pipe connecting assembly comprises an inner connecting sleeve and an inner pipe connecting seat, the front end part of the inner connecting sleeve is sleeved on the rear end part of the stroke seat, the rear end part of the inner connecting sleeve is fixedly connected with the inner pipe connecting seat, the inner pipe is fixed on the inner pipe connecting seat, and the inner connecting sleeve is provided with a connecting groove matched with the connecting part; when the interlocking and disconnecting mechanism is in the first locking state and the second locking state, the connecting part is inserted into the connecting groove to prevent the inner connecting sleeve from moving relative to the middle pipe connecting seat; when the interlocking and disconnecting mechanism is in the disconnecting state, the connecting part is separated from the connecting groove so as to allow the inner pipe connecting seat to move relative to the middle pipe connecting seat.

Furthermore, interlock and dissociation mechanism includes outer operation cover, outer operation cover in the internal connection sheathes in, the internal tube connecting seat can follow the central line passes through with moving and locates in the outer operation cover.

Furthermore, the interlocking and disconnecting mechanism further comprises a second locking piece, the second locking piece is positioned between the connecting part and the outer operating sleeve and has a first position and a second position which is positioned at a distance behind the first position, when the interlocking and disconnecting mechanism is in the first locking state, the second locking piece is positioned at the first position, the front end part of the second locking piece abuts against the connecting part, and the rear end part abuts against the outer operating sleeve; in the process of switching the interlocking and disconnecting mechanism from the first locking state to the second locking state, the outer operating sleeve moves backwards relative to the inner connecting sleeve to allow the second locking piece to move backwards; when the interlocking and disconnecting mechanism is in the disconnected state, the second locking piece is positioned at the second position.

Specifically, the second locking piece is an interlocking push rod, the interlocking push rod is located in the inner connecting sleeve, and the rear end portion of the interlocking push rod penetrates through the inner connecting sleeve and can be abutted to the rear end portion of the outer operating sleeve.

Further, when the interlock and release mechanism is in the release state, the outer operating sleeve is configured to be capable of moving rearward relative to the inner connecting sleeve; when the interlocking and dissociation mechanism is in the dissociation state, the outer operation sleeve is configured to drive the inner connection sleeve to move backwards.

Furthermore, the outer operating sleeve can be sleeved on the inner connecting sleeve in a rotating mode around the center line;

the outer operating sleeve is provided with connecting teeth, the inner connecting sleeve is provided with a first external thread, the connecting teeth can be movably inserted into the first external thread along the first external thread, the connecting teeth are arranged at the front end part of the first external thread or between the two end parts of the first external thread when the interlocking and disconnecting mechanism is in the first locking state or the second locking state, and the connecting teeth are arranged at the rear end part of the first external thread when the interlocking and disconnecting mechanism is in the disconnecting state; or the external operating sleeve is provided with internal threads, the internal connecting sleeve is provided with connecting teeth, and the connecting teeth can be movably inserted into the external threads along the external threads.

Furthermore, the front part of the inner connecting sleeve is also provided with an inner thread, the rear end part of the stroke seat is provided with a second outer thread which is matched with the inner thread, and when the interlocking and disconnecting mechanism is in the first locking state or the second locking state, the inner thread is connected with the second outer thread; when the interlock and release mechanism is in the release state, the internal thread and the second external thread are disengaged.

Further, the outer operating sleeve is a dissociation knob.

Further, in the process of switching from the first locking state to the second locking state, the interlocking and disconnecting mechanism moves the middle pipe joint seat backward to push the second locking piece to the second position, and the middle pipe joint seat then rebounds to separate the connecting part from the connecting groove of the inner connecting sleeve.

Furthermore, the operating handle further comprises a first threaded pipe which is rotatably arranged in the shell around the central line and a first operating knob which is used for driving the first threaded pipe to rotate, the first operating knob is rotatably arranged on the shell, the rotating axis line of the first operating knob is intersected with the central line, the first threaded pipe is provided with a third external thread, the third external thread is provided with a first thread circle at the rearmost side and a second thread circle adjacent to the third external thread, and a rebound groove which is used for communicating the first thread circle and the second thread circle is arranged between the first thread circle and the second thread circle; the middle pipe connecting seat is provided with a connecting lug which can be movably inserted in the third external thread along the third external thread and the rebound groove.

Specifically, the pitch between the first turn of threads and the second turn of threads gradually increases in a front-to-back direction.

Preferably, the operating handle further includes a second threaded tube rotatably disposed in the housing around the center line and a second operating knob for driving the second threaded tube to rotate, the second threaded tube is in threaded connection with the stroke seat, the second operating knob is rotatably disposed on the housing, and a rotation axis of the second operating knob intersects with the center line.

More preferably, the outer tube connecting seat is movably disposed in the housing along the center line, the operating handle further includes a third threaded tube rotatably disposed in the housing around the center line and a third operating knob for driving the third threaded tube to rotate, the third threaded tube is in threaded connection with the outer tube fixing seat, the third operating knob is rotatably disposed on the housing, and a rotation axis of the third operating knob intersects with the center line. More preferably, the operating handle further comprises an operating lever for operating a pull wire for opening the rear clamp assembly of the implant.

Further, the second operating knob is located on the front side of the stroke seat, and the third operating knob is located on the rear side of the outer tube fixing seat.

Furthermore, the rear part of the outer tube connecting seat is connected with a rear clamping assembly position indicating rod, the front part of the stroke seat is connected with a front clamping assembly position indicating rod, the shell is provided with an observation window for observing the relative position of the rear clamping assembly position indicating rod and the front clamping assembly position indicating rod, and the observation window is positioned between the outer tube connecting seat and the stroke seat.

According to a second aspect of the present invention, an implanting apparatus for a cardiac implant comprises a delivery sheath for carrying the implant and an operating handle for controlling the delivery sheath, wherein the delivery sheath comprises an outer tube, a middle tube and an inner tube which are stacked from inside to outside, and the operating handle is the operating handle for the cardiac implant as described above.

According to a third aspect of the present invention, a method of operating an operating handle of a cardiac implant, comprises the steps of:

after the front clamp assembly and the rear clamp assembly of the implant are combined, the middle pipe connecting seat of the operating handle moves backwards for a first stroke until the middle pipe connecting seat is blocked by a first locking piece, so that the front clamp assembly is closed to the minimum;

removing the first locking piece, and continuously moving the middle pipe connecting seat backwards for a second stroke so as to enable the front clamp assembly to further move backwards to be locked with the rear clamp assembly;

the inner tube attachment assembly is moved back to release the implant.

Preferably, after removing the first locking member, the following steps are performed:

rotating the dissociation knob along a first direction, and moving the dissociation knob backwards to make room for a second locking piece abutting against the rear side of the middle pipe connecting seat;

then, the first operating knob is rotated to enable the middle pipe connecting seat to move backwards for the second stroke.

More preferably, the middle pipe connecting seat moves backwards for the second stroke and then rebounds to the first stroke, so that the connecting part of the middle pipe connecting seat exits from the inner pipe connecting assembly.

More preferably, the step of moving back the inner tube connecting assembly specifically comprises:

after the middle tube connecting seat and the inner tube connecting assembly are separated, the disconnecting knob is rotated along the first direction, so that the inner tube connecting assembly is released, and the inner tube and the implant are allowed to be separated and withdrawn.

In a specific and preferred embodiment, the above-mentioned operating handle is adopted, and the operating method is implemented as follows:

s1, opening the front clamp assembly by rotating a first operating knob, opening the rear clamp assembly by operating an operating rod, and combining the front clamp assembly and the rear clamp assembly by rotating a second operating knob and a third operating knob to control a stroke seat and an outer tube connecting seat to move;

s2, the middle pipe connecting seat moves backwards for a first stroke by rotating the first operating knob until the middle pipe connecting seat is blocked by the first locking piece, so that the front clamp assembly is closed to the minimum;

s3, removing the first locking piece;

s4, rotating the dissociation knob along the first direction to enable the dissociation knob to move backwards relative to the inner pipe connecting assembly to make room for a second locking piece abutting against the rear side of the middle pipe connecting seat;

s5, operating the first operating knob to enable the middle pipe connecting seat to continuously move backwards for a second stroke, so that the front clamp assembly further moves backwards to be locked with the rear clamp assembly; thereafter, the middle pipe connecting seat rebounds forward under the tension of the middle pipe to withdraw the inner pipe connecting assembly, thereby allowing the inner pipe connecting assembly to rotate;

s6, continuing to rotate the dissociation knob along the first direction to enable the dissociation knob to be separated from the stroke seat, and enabling the inner tube connecting assembly to rotate to release the implant.

Compared with the prior art, the invention has the following advantages by adopting the scheme:

according to the operating handle, the implantation instrument and the operating method, the interlocking and dissociating mechanism is arranged between the stroke seat and the inner tube connecting assembly, the inner tube connecting assembly cannot move independently before the interlocking and dissociating mechanism dissociates, after all actions of the stroke seat on the front side and the middle tube connecting seat are carried out, the inner tube connecting assembly dissociates, at the moment, the inner tube can be operated to release the cardiac implant or further withdraw the conveying sheath tube, logic interlocking is carried out, misoperation is prevented, and surgical risks such as mitral valve repair are reduced.

Drawings

In order to more clearly illustrate the technical solution of the present invention, the drawings required to be used in the description of the embodiments will be briefly introduced below, and it is apparent that the drawings in the description below are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained based on these drawings without creative efforts.

Fig. 1 is a perspective view of an insertion instrument for a cardiac implant according to an embodiment of the present invention.

Fig. 2 is a cross-sectional view of the insertion instrument of fig. 1.

Fig. 3 is a sectional view of a front portion of an operating handle according to an embodiment of the present invention.

Fig. 4 is a sectional view of a front portion of an operating handle according to an embodiment of the present invention.

Fig. 5 is a schematic view of the position of the middle pipe connecting seat at the rightmost and the first threaded pipe before the shear pin is removed according to the embodiment of the invention.

Fig. 6 is a schematic diagram illustrating the rightmost position of the middle pipe connecting seat and the first threaded pipe after the shear pin is removed according to the embodiment of the present invention.

Fig. 7 is a schematic diagram illustrating the position of the middle pipe connecting socket after being rebounded and the first threaded pipe according to the embodiment of the present invention.

Fig. 8 is a schematic structural view of the rear portion of the operating handle according to the embodiment of the present invention, in which the interlock and release mechanism is switched from the first locking state to the second locking state or from the second locking state to the release state.

Fig. 9 is a schematic structural view of the rear part of the operating handle according to the embodiment of the present invention, in which the interlocking and shortcut mechanism is in a disconnected state.

Fig. 10 is a block diagram of an inner tube connecting assembly and an interlocking push rod according to an embodiment of the present invention.

FIG. 11 is a block diagram of an inner coupling sleeve according to an embodiment of the present invention.

Fig. 12 is a structural view illustrating the connection of an inner pipe connection socket and a rear end portion of an inner pipe according to an embodiment of the present invention.

Fig. 13 is a block diagram of a detachment knob according to an embodiment of the present invention.

Fig. 14 is a block diagram of an interlocking push rod according to an embodiment of the present invention.

Fig. 15 is a schematic view of an application of the cardiac implant.

Reference numerals:

100. an operating handle; 200. a delivery sheath; 300. an implant;

201. an outer tube; 202. a middle pipe; 203. an inner tube; 204. a pull wire;

301. a front clamp assembly; 302. a rear clamp assembly;

1. a housing; 11. an observation window;

2. an outer tube connecting seat; 21. a third threaded pipe; 22. a third operation knob; 23. an operating lever; 24. a rear clamp assembly position indicating rod;

3. a stroke seat; 30. a second external thread; 31. a second threaded pipe; 32. a second operation knob; 33. a front clamp assembly position indicating bar;

4. a middle pipe connecting seat; 40. a limiting part; 41. a connecting portion; 42. a first threaded pipe; 420. a third external thread; 420a, a first turn of threads; 420b, a second turn of threads; 421. a rebound groove; 43. a first operation knob; 44. a connecting lug;

5. an inner tube connecting assembly; 51. an inner connecting sleeve; 510. a first external thread; 511. an internal thread; 512. connecting grooves; 513. a pin hole; 52. an inner tube connecting seat;

6. an interlock and disconnect mechanism; 61. a bolt; 62. A dissociation knob; 621. a connecting tooth; 622. a pin hole; 63. an interlocking push rod; 631. a rear end portion;

C. a centerline.

Detailed Description

Preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings so that the advantages and features of the invention may be more readily understood by those skilled in the art. It should be noted that the description of the embodiments is provided to help understanding of the present invention, but the present invention is not limited thereto.

The embodiment relates to a medical instrument for interventional therapy of structural heart disease, in particular to an operating handle of a heart implant for mitral valve edge-to-edge repair surgery and an implant instrument with the operating handle. Referring to fig. 1-15, the manipulation handle 100 of the cardiac implant is used to manipulate the delivery sheath 200 so that the implant 300 grips the cardiac tissue and is withdrawn after being closed in place. Specifically, the implanting apparatus for the cardiac implant mainly includes a delivery sheath 200 for carrying the implant 300 and an operation handle 100 for controlling the delivery sheath 200, and the delivery sheath 200 includes an outer tube 201, a middle tube 202 and an inner tube 203 which are laminated from inside to outside. As shown in fig. 15, the implant 300 mainly comprises a front clamp assembly 301 and a rear clamp assembly 302, wherein the front clamp assembly 301 and the rear clamp assembly 302 can be opened and closed respectively, and the front clamp assembly 301 and the rear clamp assembly 302 can also move relatively and can be locked with each other. The outer tube 201 is detachably connected with the rear clamp assembly 302, the middle tube 202 is detachably connected with the two clamping arms 3011 of the front clamp assembly 301, and the inner tube 203 is detachably connected with the main base of the front clamp assembly 301; the inner pipe 203 and the front clamp assembly 301 are connected through threads, and can be separated after rotating for a certain number of turns in a specific direction (such as anticlockwise direction), the middle pipe 202 and the clamping arm 3011 of the front clamp assembly 301 are connected through a separable elastic connecting buckle, and when the inner pipe 203 is withdrawn from the middle pipe 202, the elastic connecting buckle is reset inwards to separate the middle pipe 202 from the clamping arm 301; similarly, the outer tube 201 and the rear clamp assembly 302 are also connected by releasable elastic connecting buckles, and when the middle tube 202 is withdrawn from the outer tube 201, the elastic connecting buckles are reset inwards to separate the outer tube 201 and the rear clamp assembly 302. The delivery sheath 200 and the implant 300 are not essential to the invention of the present application, and a structure known in the prior art may be adopted, for example, the distal end of the delivery sheath 200 is provided with a delivery interface of a human heart implant device as disclosed in patent document CN113476182B, the implant 300 is connected through the delivery interface, and the implant 300 is a medical device with adjustable clamping manner as disclosed in patent document CN113768554 a.

In this embodiment, and as shown in connection with fig. 15, the logic for operating implant 300 generally includes the following acts: (1) After the delivery sheath 200 delivers the implant 300 to the region of the heart to be placed, the middle tube 202 moves forward to drive the front clamp assembly 301 to open; (2) The middle pipe 202 and the inner pipe 203 synchronously move forward to drive the front clamp assembly 301 to move forward; releasing the pull wire 204 to open the rear clamp assembly 302 (the rear clamp assembly 302 is in a deployed state in a natural state, the pull wire 204 is pulled backwards to retract the rear clamp assembly 302 when the delivery sheath 200 is delivered in the blood vessel, and when the action (2) is executed, the pull wire 204 is released forwards, and the rear clamp assembly 302 is automatically opened); (3) The outer tube 201 is advanced to bring the rear clamp assembly 302 closer to the front clamp assembly 301 until the two merge; (4) The middle tube 202 moves backwards a distance to close the front clamp assembly 301; (5) The middle tube 202 moves further backward, so that the front clamp assembly 301 and the rear clamp assembly 302 are locked with each other, specifically, the two clamping arms 3011 of the front clamp assembly 301 and the rear clamp assembly 302 are locked, and the two clamping arms 3011 are clamped between the two elastic arms 3012 of the front clamp assembly 301; (6) The inner tube 203, middle tube 202, outer tube 201 are sequentially disconnected from the implant 300, the implant 300 is released, and the delivery sheath 200 is withdrawn from the patient. The operation handle 100 of the present embodiment interlocks the control logics corresponding to the above-mentioned operation sequence, and the next operation cannot be performed before the previous operation is completed, thereby effectively preventing the occurrence of the misoperation. The operating handle 100 that executes this operating logic is described in detail below.

Referring to fig. 2, 3 and 4, the operating handle 100 includes a housing 1, and an outer tube connecting seat 2, a middle tube connecting seat 4 and an inner tube connecting assembly 5 respectively connected to an outer tube 201, a middle tube 202 and an inner tube 203 of a sheath tube 200, wherein the outer tube connecting seat 2, the middle tube connecting seat 4 and the inner tube connecting assembly 5 are sequentially disposed from front to back. The sheath 1 has a center line C extending in the longitudinal direction of the delivery sheath 200. Herein, the terms "front" and "rear" are defined in terms of the angle of view of the operator, with the side farther from the operator being the front and the opposite being the outside.

The operating handle 100 further comprises a stroke seat 3 located behind the outer tube connecting seat 2, the stroke seat 3 is movably connected to the outer shell 1 along a center line C, the middle tube connecting seat 4 is movably arranged on the stroke seat 3 along the center line C, and an interlocking and dissociation mechanism 6 is arranged between the inner tube connecting assembly 5 and the stroke seat 3. The interlock and release mechanism 6 has a locked state (including a first locked state and a second locked state) and a released state. In a first locking state, the rear end part of the stroke seat 3 is connected with the inner pipe connecting assembly 5 and is locked by the interlocking and disconnecting mechanism 6, and the middle pipe connecting seat 4 can move in a first stroke; in a second locked state, the rear end portion of the stroke seat 3 is connected to the inner pipe connecting assembly 5 and locked by the interlock and release mechanism 6, and the middle pipe connecting seat 4 is movable in a second stroke located on the rear side of the first stroke; in the disengaged state, the inner tube connecting assembly 5 is released to be able to move backward along the center line C relative to the stroke seat 3 and the middle tube 202. Before the action (5) is executed, the interlocking and disconnecting mechanism 6 is always in a first locking state; when the action (5) is executed, the interlocking and disconnecting mechanism 6 is switched to a second locking state; when the operation (6) is performed, the interlock and release mechanism 6 is switched to the release state. Middle tube connector seat 4 has two strokes, the displacement stroke (first stroke) of middle tube connector seat 4 is only enough to close front clamp assembly 301 and rear clamp assembly 302 of implant 300 before removing the safety pin, inner tube connector seat 4 can move backward continuously after removing the safety pin and lock front clamp assembly 301 and rear clamp assembly 302, and finally rebound to release the tension in middle tube 202 after reaching the end. Figure 5 shows the end of the mid-level pipe coupling socket 4 in the first stroke; figures 6 and 7 show the end and start points, respectively, of the mid-level pipe coupling seat 4 in the second stroke.

As shown in fig. 3, 8 and 9, the interlock and release mechanism 6 includes a first locking member, and when the interlock and release mechanism 6 is in the first locking state, the first locking member is located behind the stroke seat 3 or abuts against the stroke seat 3; when the interlock and release mechanism 6 is in the second locking state and the release state, the first locking member is far away from the rear part of the stroke seat 3. Specifically, the first locking member is a bolt 61, a bolt hole 513 into which the bolt 61 can be inserted is formed in the inner pipe connecting assembly 5, and the middle pipe connecting base 4 further has a limiting portion 40 for engaging with the bolt 61. When the interlocking and disconnecting mechanism 6 is in a first locking state, the front end part of the inner pipe connecting assembly 5 is sleeved on the rear end part of the stroke seat 3, the bolt 61 is inserted into the bolt hole 513, and the limiting part 40 is positioned in front of the bolt 61 or is abutted against the bolt 61; the latch 61 is disengaged from the latch hole 513 when the interlock and release mechanism 6 is in the second locked state and the released state. The distance that connector 4 moves backwards is limited by safety pin 61, and safety pin 61 is positioned such that implant 300 is closed to a minimum angle (i.e., the distance between clamp arms 3011 of front clamp assembly 301 and rear clamp assembly 302 is at a minimum). The inner tube connecting assembly 5 is connected to the end of the travel base 3 by an interlock and release mechanism 6, and can move back and forth with the travel base 3, and the inner tube 203 can be considered to move in a binding manner with the travel base 3 before the safety latch 61 is removed.

The middle tube connecting socket 4 also has a connecting portion 41. As shown in fig. 8 and 9, the inner tube connecting assembly 5 includes an inner connecting sleeve 51 and an inner tube connecting seat 52, a front end of the inner connecting sleeve 51 is sleeved on a rear end of the stroke seat 3, a rear end of the inner connecting sleeve 51 is fixedly connected to the inner tube connecting seat 52, and the inner tube 203 is fixed to the inner tube connecting seat 52. The inner coupling sleeve 51 has a coupling groove 512 to be coupled with the coupling portion 41. When the interlocking and disconnecting mechanism 6 is in the first locking state and the second locking state, the connecting portion 41 is inserted into the connecting groove 512 to prevent the inner connecting sleeve 51 from moving relative to the fixed seat of the middle tube 202; when the interlock and release mechanism 6 is in the released state, the connecting portion 41 is disengaged from the connecting groove 512 to allow the inner pipe connecting seat 52 to move relative to the fixed seat of the middle pipe 202.

The interlocking and dissociation mechanism 6 comprises an outer operating sleeve which is sleeved on an inner connecting sleeve 51, and an inner pipe connecting seat 52 can be movably arranged in the outer operating sleeve along a central line C. The outer operating sleeve can be sleeved on the inner connecting sleeve 51 in a rotating way around the central line C; when the interlock and release mechanism 6 is in the release state, the outer operating sleeve is configured to be able to move backward relative to the inner connecting sleeve 51; the outer operating sleeve is configured to move the inner connecting sleeve 51 rearward when the interlock and release mechanism 6 is in the release state. Specifically, the outer operating sleeve is a release knob 62. The pin hole 513 is formed in the inner connection sleeve 51, and the release knob 62 is also formed with a pin hole 622, and the pin 61 is inserted into the pin hole 513 and the pin hole 622.

Referring to fig. 8 to 14, the interlock and release mechanism 6 further includes a second locking member. Specifically, the second locking member is an interlock plunger 63, the interlock plunger 63 is located in the inner connecting sleeve 51, and a rear end 631 of the interlock plunger 63 passes through the inner connecting sleeve 51 and can abut against a rear end of the release knob 62. An interlock push rod 63 is provided between the connecting portion 41 and the release knob 62 and has a first position and a second position located at a distance behind the first position. When the interlock and release mechanism 6 is in the first locked state, the interlock push rod 63 is located at the first position, the front end of the interlock push rod 63 abuts against the connecting part 41, and the rear end 631 abuts against the release knob 62; in the process of switching the interlocking and disconnecting mechanism 6 from the first locking state to the second locking state, the disconnecting knob 62 moves backwards relative to the inner connecting sleeve 51 to allow the interlocking push rod 63 to move backwards; when the interlock and release mechanism 6 is in the release state, the interlock plunger 63 is in the second position.

Specifically, in the present embodiment, as shown in fig. 8, 9, 11 and 13, the separation knob 62 is provided with a connecting tooth 621, the inner connecting sleeve 51 is provided with a first external thread 510 (for example, 6 turns), and the connecting tooth 621 is movably inserted into the first external thread 510 along the first external thread 510. The interlocking and disconnecting mechanism 6 has the connecting tooth 621 at the front end portion of the first external thread 510 or between both end portions thereof in the first locked state or the second locked state; the interlocking and disconnecting mechanism 6 is with the connecting tooth 621 at the rear end of the first external thread 510 in the disconnected state. Rotating the disengagement knob 62 counterclockwise retracts the disengagement knob 62 6 revolutions back and stops. Simultaneously, the release knob 62 will rotate the inner tube connecting seat 52 counterclockwise by 6 turns. The inner sleeve 51 and the release knob 62 are restrained from rotation by the latch 61 until the latch 61 is removed. In other embodiments, the release knob 62 is provided with an internal thread, and the inner connecting sleeve 51 is provided with a connecting tooth, which can be movably inserted into the external thread along the external thread.

Further, the front portion of the inner connecting sleeve 51 is provided with an internal thread 511 (for example, 2 turns), and the rear end portion of the stroke seat 3 is provided with a second external thread 30 (for example, 2 turns). When the interlock and release mechanism 6 is in the first locked state or the second locked state, the internal thread 511 and the second external thread 30 are connected; when the interlock and release mechanism 6 is in the release state, the internal thread 511 and the second external thread 30 are disengaged. Inner connecting sleeve 51 is connected to the tail of stroke seat 3 through 2 circles of threads, and can fall and move backwards after rotating 2 circles anticlockwise, but before rotating, middle pipe connecting seat 4 needs to be rotated after being withdrawn forwards from inner connecting sleeve 51, and the inner connecting sleeve 51 is withdrawn through the following rebound operation.

Further, in the process of switching from the first locking state to the second locking state, the interlock and release mechanism 6 moves the middle pipe joint holder 4 backward to push the interlock push rod 63 to the second position, and the middle pipe joint holder 4 rebounds to separate the connecting portion 41 from the connecting groove 512 of the inner connecting sleeve 51. Specifically, the operating handle 100 further includes a first threaded tube 42 rotatably disposed in the housing 1 about the center line C and a first operating knob 43 for rotating the first threaded tube 42. The first operation knob 43 is rotatably disposed on the housing 1, and a rotation axis line of the first operation knob 43 intersects with the center line C, which is perpendicular in this embodiment. The first threaded pipe 42 has a third external thread 420, the third external thread 420 has a rearmost first turn 420a and a second turn 420b adjacent thereto, a resilient groove 421 communicating the first and

second turns

420a and 420b is provided therebetween, and a pitch between the first and

second turns

420a and 420b is gradually increased in a front-to-rear direction. The middle pipe connecting seat 4 has a connecting lug 44, and the connecting lug 44 is movably inserted in the third external thread 420 along the third external thread 420 and the resilient groove 421. The middle pipe connecting seat 4 is driven by the pulling force of the middle pipe 202 to rebound, so as to release the stress of the middle pipe 202 in the locking process. That is, the third external thread 420 is two reducing double spirals, the closer to the rear end, the larger the pitch, and a rebound groove 421 leading through the last but one turn of thread 420b is formed at the end of the last first turn of thread 420 a; the stroke seat 3 and the third knob external thread pipe are connected with each other through two connecting lugs 44 at both sides of the middle pipe connecting seat 4. Because middle pipe connecting seat 4 can receive the pulling force to the left after moving backward to a certain extent, after third external screw thread 420 end, can drop to in the penultimate thread (namely second circle of screw thread 420 b).

The operating handle 100 further includes a second threaded pipe 31 rotatably disposed in the housing 1 about the center line C and a second operating knob 32 for rotating the second threaded pipe 31. The second screw tube 31 is screwed with the stroke seat 3, the second operation knob 32 is rotatably provided on the housing 1, and the rotation axis line of the second operation knob 32 intersects with the center line C, which is perpendicular in this embodiment.

The outer tube connecting seat 2 is movably disposed in the housing 1 along the center line C, and the operating handle 100 further includes a third threaded tube 21 rotatably disposed in the housing 1 around the center line C and a third operating knob 22 for driving the third threaded tube 21 to rotate. The third threaded pipe 21 is in threaded connection with the fixed base of the outer pipe 201, the third operating knob 22 is rotatably arranged on the housing 1, and the rotating axis line of the third operating knob 22 intersects with the center line C, which is vertical in the embodiment. The operating handle 100 further includes an operating lever 23 for manipulating the pull wire 204 to open or position the rear clamp assembly 302 of the implant 300; specifically, when the pull wire 204 is pulled backward, the rear clamp assembly 302 is closed, and when the pull wire 204 is released, the rear clamp assembly 302 is automatically opened.

Referring to fig. 1 to 4, the second operating knob 32 is located at the front side of the stroke seat 3, and the third operating knob 22 is located at the rear side of the outer tube 201 fixing seat. The rear portion of outer tube connecting seat 2 is connected with back clamp assembly position indication stick 24, and the front portion of stroke seat 3 is connected with preceding clamp assembly position indication stick 33, is equipped with the observation window 11 that is used for observing the relative position of back clamp assembly position indication stick 24 and preceding clamp assembly position indication stick 33 on the shell 1, and observation window 11 is located between outer tube connecting seat 2 and stroke seat 3. Referring to fig. 1, the first operation knob 43, the second operation knob 32, and the third operation knob 22 are provided in pairs on both left and right sides of the housing 1, and are spaced apart from the rear to the front, and the observation window 11 is located between the second operation knob 32 and the third operation knob 22; the release knob 62 is located on the rear end portion of the entire operation handle 100, and is disposed coaxially with the housing 1. The third operating knob 22 and the third threaded pipe 21 are in transmission through a bevel gear or friction transmission, the outer pipe connecting seat 2 can be driven to move back and forth by rotating the third operating knob 22, and the outer pipe 201 drives the rear clamp assembly 302 to move horizontally; the second operating knob 32 and the second threaded pipe 31 are in transmission through a bevel gear or friction transmission, the stroke seat 3 can be driven to move back and forth by rotating the second operating knob 32, the middle pipe 202 and the inner pipe 203 synchronously move with the middle pipe to drive the front clamp assembly 301 to integrally translate (wherein, the middle pipe 202 is connected with a first base point of the front clamp assembly 301, the inner pipe 203 is connected with a second base point of the front clamp assembly 301, and the first base point and the second base point can synchronously move and can also relatively move); the first operating knob 43 and the first threaded pipe 42 are in bevel gear transmission or friction transmission, the middle pipe connecting seat 4 can be driven to move back and forth by rotating the first operating knob 43, and the outer pipe 201 drives the front clamp assembly 301 to open or close (the first base point is close to or far away from the second base point); rotation of the release knob 62 rotates the inner tube, releasing the threaded connection with the implant 300 and releasing the implant 300. The release knob 62 is connected to the travel base 3 without moving or rotating when the implant is operated; rotated while performing the dissociation step. Since the implant 300 requires a 6-turn counterclockwise rotation of the inner tube 203 before locking; rotating counterclockwise to disengage upon release of the front clip assembly 301. Thus, the release knob 62 is configured for two gears, a first gear of 6 rotations and a second gear of infinite rotations. A safety latch 61 is placed on the release knob 62 to prevent the surgeon from misoperating the release member before manipulating the implant 300 to the desired target site; meanwhile, the safety latch 61 can block the middle tube 202 operated by the first operating knob 43, so as to prevent the doctor from mistakenly locking before reaching the target position.

After confirming that the anterior clamp assembly 301 and the posterior clamp assembly 302 of the implant 300 are closed, the logical sequence that needs to be performed is: the inner tube 203 is rotated counterclockwise 6 turns; the middle pipe 202 retreats 6mm backwards and then retreats to release tension; the inner tube 203 continues to rotate counterclockwise until disengaged. The operation of the operating handle 100 corresponds to: after the front clamp assembly 301 and the rear clamp assembly 302 of the implant 300 are confirmed to be closed, the bolt 61 is removed, and before the next action is executed, the middle pipe connecting seat 4 cannot be continuously withdrawn due to the limit of the interlocking push rod 63; rotating the release knob 62 counterclockwise, which will drive the inner tube connecting seat to rotate 6 turns counterclockwise, but not move forward and backward, which will drive the inner tube to rotate 6 turns counterclockwise; rotating the first operating knob 43 to make the middle tube connecting seat 4 retreat to the end; the middle pipe connecting seat 4 can automatically rebound to release tension due to the pulling force of the middle pipe 202 after retreating to the tail, before the step, the dissociation knob 62 cannot rotate due to the fact that the rear end of the middle pipe connecting seat 4 is arranged in the inner connecting sleeve 51, and the middle pipe 202 retreats 6mm in the step and then retreats to release tension; the hour hand rotates the release knob 62 to disengage, and in this step, the release knob 62 drives the inner connection sleeve 51 to rotate as the middle tube connection seat 4 withdraws from the inner connection sleeve 51. The inner connection sleeve 51 is peeled off from the stroke seat 3 after two rotations, and can be rotated infinitely until the inner connection sleeve is separated.

The present embodiment also provides a method of operating the operating handle 100 of the cardiac implant 300, the operating handle 100 being the operating handle 100 described above, for non-diagnostic and therapeutic purposes. The operation method comprises the following steps:

after front clamp assembly 301 and rear clamp assembly 302 of implant 300 are combined, middle tube connecting seat 4 moves backward by a first stroke until being blocked by a first locking member to close front clamp assembly 301 to the minimum;

removing the first locking member, and continuing to move back the middle pipe connecting seat 4 by a second stroke, so that the front clamp assembly 301 moves back further to be locked with the rear clamp assembly 302;

the inner-tube connecting assembly 5 is moved backward, releasing the implant 300.

Further, after removing the plug 61, the following steps are performed:

rotating the dissociation knob 62 along the first direction, and moving the dissociation knob 62 backwards to make room for the interlocking push rod 63 abutting against the rear side of the middle pipe connecting seat 4;

then, the first operating knob 43 is rotated to move the middle pipe joint holder 4 backward by a second stroke.

Further, middle pipe connecting holder 4 moves backward for a second stroke and then rebounds to the first stroke to enable connecting portion 41 of middle pipe connecting holder 4 to exit inner pipe connecting assembly 5.

Further, the step of moving the inner tube connecting assembly 5 backward specifically includes:

after the tube coupling receptacle 4 and the inner tube coupling assembly 5 are disengaged, the inner tube coupling assembly 5 is released by rotating the release knob 62 in the first direction, allowing the inner tube 203 and the implant 300 to disengage and be withdrawn.

The operation method is implemented as follows:

s1, a first operation knob 43 is rotated to open a front clamp assembly 301, an operation rod 23 is operated to open a rear clamp assembly 302, and a second operation knob 32 and a third operation knob 22 are rotated to control a stroke seat 3 and an outer pipe connecting seat 2 to move so as to combine the front clamp assembly 301 and the rear clamp assembly 302;

s2, the middle pipe connecting seat 4 moves backwards for a first stroke by rotating the first operating knob 43 until the middle pipe connecting seat is blocked by the bolt 61, so that the front clamp assembly 301 is closed to the minimum;

s3, removing the bolt 61;

s4, rotating the dissociation knob 62 along the first direction to enable the dissociation knob 62 to move backwards relative to the inner pipe connecting assembly 5 to make room for the interlocking push rod 63 abutting against the rear side of the middle pipe connecting seat 4;

s5, operating the first operating knob 43 to enable the middle pipe connecting seat 4 to move backwards continuously for a second stroke, so that the front clamp assembly 301 moves backwards further to be locked with the rear clamp assembly 302; thereafter, the middle pipe joint holder 4 springs back forward under the tension of the middle pipe 202 to withdraw the inner pipe joint assembly 5, thereby allowing the inner pipe joint assembly 5 to rotate;

s6, continuing to rotate the detachment knob 62 in the first direction disengages the detachment knob 62 from the travel base 3, and rotating the inner tube connecting assembly 5 to release the implant 300.

The operation of the operating handle 100 described above is substantially as follows:

1. after the delivery sheath 200 has delivered the implant 300 to a target point where manipulation is required, the first manipulation knob 43 is rotated to move the middle tube 202 forward to open the front clamp assembly 301 of the implant 300.

2. By rotating the second operating knob 32 to simultaneously move the middle tube 202 and the inner tube 203 forward, the front clamp assembly of the implant 300 is integrally translated forward.

3. Pushing the two side levers 23 downward causes the rear clamp assembly 302 of the implant 300 to open;

4. rotating the third operating knob 22 moves the outer tube 201 forward while observing the observation window 11, and the upper front clamp assemblies are combined.

5. Rotation of the first operating knob 43 moves the middle tube 202 back to the latch 61, which is prevented from further movement due to the latch 61, and closes the front clamp assembly to a minimum.

At this point, the dissociation process is started, with interlock logic:

6. in the previous operation, when the middle tube connecting base 4 is retreated, the second step of the release knob 62 is locked so as not to rotate infinitely (the connecting portion 41 is inserted into the inner connecting sleeve 51). At this point, the latch 61 is removed and the release knob 62 is rotated counterclockwise 6 turns to bring the implant 300 into the locked position.

With the latch 61 removed, the release knob 62 is rotated 6 turns to clear the position, where the first operating knob 43 can be operated to continue to retract until the implant 300 is locked and the locked implant 300 cannot be opened. After the implant 300 is locked, due to the diameter-variable and resilient design of the third external thread 420, the locked middle tube 202 and middle tube connecting base 4 will resiliently withdraw from the inner connecting sleeve 51, and the second stop of the release knob 62 is opened.

7. The fourth knob is rotated counterclockwise until withdrawal is possible, indicating release of the implant 300.

In the present embodiment, after the operation handle 100 for operating the implant 300 confirms that the implant 300 is closed to the minimum, the operation sequence needs to be as follows, the plug pin 61 is pulled out → the detachment knob 62 is rotated for six turns (the first operation knob 43 can be continuously rotated backward only after the detachment knob 62 is rotated for 6 turns) → the first operation knob 43 is rotated backward to lock the front clamp assembly 301 and the rear clamp assembly 302 (the detachment knob 62 can be infinitely rotated counterclockwise only after the front clamp assembly 301 and the rear clamp assembly 302 are locked) → the detachment knob 62 is infinitely rotated and released.

It should be noted that, unless otherwise specified, when a feature is referred to as being "fixed" or "connected" to another feature, it can be directly fixed or connected to the other feature or indirectly fixed or connected to the other feature. In addition, the descriptions of the upper, lower, left, right, etc. used in the present invention are only relative to the mutual positional relationship of the components of the present invention in the drawings, and reference is made to fig. 2.

It is further understood that the use of "a plurality" in this disclosure means two or more, as other terms are analogous. "and/or" describes the association relationship of the associated objects, meaning that there may be three relationships, e.g., a and/or B, which may mean: a exists alone, A and B exist simultaneously, and B exists alone.

It will be further understood that the terms "first," "second," and the like, are used to describe various information and should not be limited by these terms. These terms are only used to distinguish one type of information from another and do not denote a particular order or importance. Indeed, the terms "first," "second," and the like are fully interchangeable. For example, first information may also be referred to as second information, and similarly, second information may also be referred to as first information, without departing from the scope of the present disclosure.

The above embodiments are merely illustrative of the technical ideas and features of the present invention, and are preferred embodiments, which are intended to enable those skilled in the art to understand the contents of the present invention and implement the present invention, and not to limit the scope of the present invention. All equivalent changes or modifications made according to the principles of the present invention should be covered within the protection scope of the present invention.

Claims

1. An operating handle of a cardiac implant is used for operating a delivery sheath so that the implant clamps cardiac tissue, and is characterized by comprising a shell, an outer tube connecting seat, a middle tube connecting seat and an inner tube connecting assembly, wherein the outer tube connecting seat, the middle tube connecting seat and the inner tube connecting assembly are respectively used for being connected with an outer tube, a middle tube and an inner tube of the delivery sheath;

2. The manipulating handle for cardiac implant according to claim 1, wherein the interlocking and disconnecting mechanism has a second locking state in which the middle tube connecting seat is movable in a first stroke; in the second locked state, the rear end portion of the stroke seat is connected to the inner pipe connecting assembly and locked by the interlock and release mechanism, and the middle pipe connecting seat is movable in a second stroke located on the rear side of the first stroke.

3. The manipulating handle according to claim 2, wherein the interlocking and releasing mechanism comprises a first locking member, and the first locking member is located behind or abutted against the stroke seat when the interlocking and releasing mechanism is in the first locking state; when the interlocking and disconnecting mechanism is in the second locking state and the disconnecting state, the first locking piece is far away from the rear part of the stroke seat.

4. The operating handle of cardiac implant according to claim 3, wherein the first locking member is a bolt, the inner tube connecting assembly has a bolt hole for inserting the bolt, and the middle tube connecting base further has a limiting portion for engaging with the bolt; when the interlocking and disconnecting mechanism is in the first locking state, the front end part of the inner pipe connecting assembly is sleeved on the rear end part of the stroke seat, the bolt is inserted into the bolt hole, and the limiting part is positioned in front of the bolt or is abutted against the bolt; when the interlocking and disconnecting mechanism is in the second locking state and the disconnecting state, the bolt is separated from the bolt hole.

5. The manipulating handle for cardiac implant according to claim 4, wherein the middle tube connecting seat further has a connecting portion, the inner tube connecting assembly comprises an inner connecting sleeve and an inner tube connecting seat, a front end portion of the inner connecting sleeve is sleeved on a rear end portion of the stroke seat, a rear end portion of the inner connecting sleeve is fixedly connected with the inner tube connecting seat, the inner tube is fixed on the inner tube connecting seat, and the inner connecting sleeve has a connecting groove matched with the connecting portion; when the interlocking and disconnecting mechanism is in the first locking state and the second locking state, the connecting part is inserted into the connecting groove to prevent the inner connecting sleeve from moving relative to the middle pipe connecting seat; when the interlocking and disconnecting mechanism is in the disconnecting state, the connecting part is separated from the connecting groove so as to allow the inner pipe connecting seat to move relative to the middle pipe connecting seat.

6. The manipulating handle according to claim 5, wherein the interlocking and releasing mechanism comprises an outer manipulating sleeve sleeved on the inner connecting sleeve, and the inner connecting seat is movably inserted into the outer manipulating sleeve along the central line; the interlocking and disconnecting mechanism further comprises a second locking piece, the second locking piece is positioned between the connecting part and the outer operating sleeve and is provided with a first position and a second position which is positioned at a distance behind the first position, when the interlocking and disconnecting mechanism is in the first locking state, the second locking piece is positioned at the first position, the front end part of the second locking piece abuts against the connecting part, and the rear end part abuts against the outer operating sleeve; in the process of switching the interlocking and disconnecting mechanism from the first locking state to the second locking state, the outer operating sleeve moves backwards relative to the inner connecting sleeve to allow the second locking piece to move backwards; when the interlocking and disconnecting mechanism is in the disconnecting state, the second locking piece is located at the second position.

7. The manipulating handle for cardiac implant according to claim 6, wherein said second locking member is an interlocking pushing rod, said interlocking pushing rod being located in said inner connecting sleeve, a rear end portion of said interlocking pushing rod passing through said inner connecting sleeve and being capable of abutting against a rear end portion of said outer manipulating sleeve.

8. The manipulating handle for cardiac implant according to claim 6, wherein said outer manipulating sleeve is configured to be moved backward relative to said inner connecting sleeve when said interlocking and unlocking mechanism is in said unlocked state; when the interlocking and dissociation mechanism is in the dissociation state, the outer operation sleeve is configured to drive the inner connection sleeve to move backwards.

9. The manipulating handle according to claim 8, wherein said outer manipulating sleeve is rotatably fitted over said inner connecting sleeve about said center line;

10. The manipulating handle for cardiac implant according to any one of claims 5 to 9, wherein the inner connecting sleeve is further provided at its front portion with an internal thread, and the stroke seat is provided at its rear end portion with a second external thread, the internal thread and the second external thread being coupled when the interlocking and disconnecting mechanism is in the first locking state or the second locking state; when the interlocking and disconnecting mechanism is in the disconnected state, the internal thread and the second external thread are separated.

11. The operating handle of a cardiac implant according to any of claims 6 to 9, wherein the outer operating sheath is a release knob.

12. The manipulating handle for cardiac implant according to any one of claims 7 to 9, wherein said interlocking and releasing mechanism moves said middle tube connecting holder backward to push said second locking member to said second position during the switching from said first locking state to said second locking state, and said middle tube connecting holder then rebounds to disengage said connecting portion from said connecting groove of said inner connecting sleeve.

13. The operating handle for cardiac implant according to claim 12, further comprising a first threaded tube rotatably disposed in the housing about the center line and a first operating knob for rotating the first threaded tube, the first operating knob being rotatably disposed on the housing, a rotation axis of the first operating knob intersecting the center line, the first threaded tube having a third external thread, the third external thread having a last first thread turn and a second thread turn adjacent thereto, the first thread turn and the second thread turn having a rebound groove therebetween for communicating the first thread turn and the second thread turn; the middle pipe connecting seat is provided with a connecting lug which can be movably inserted in the third external thread along the third external thread and the rebound groove.

14. The manipulating handle for a cardiac implant according to claim 13, wherein a pitch between the first turn of threads and the second turn of threads is gradually increased in a front-to-rear direction.

15. The operating handle for a cardiac implant according to claim 1, further comprising a second threaded tube rotatably disposed in the housing about the center line and a second operating knob for driving the second threaded tube to rotate, wherein the second threaded tube is threadedly connected to the stroke seat, the second operating knob is rotatably disposed on the housing, and a rotation axis of the second operating knob intersects with the center line.

16. The operating handle for cardiac implant according to claim 15, wherein the outer tube connecting seat is movably disposed in the housing along the center line, the operating handle further comprises a third threaded tube rotatably disposed in the housing around the center line and a third operating knob for driving the third threaded tube to rotate, the third threaded tube is in threaded connection with the outer tube fixing seat, the third operating knob is rotatably disposed on the housing, and a rotation axis of the third operating knob intersects with the center line; the operating handle further includes an operating lever for manipulating a pull wire that opens a rear clamp assembly of the implant.

17. The operating handle for a cardiac implant according to claim 16, wherein the second operating knob is located on a front side of the stroke seat and the third operating knob is located on a rear side of the outer tube holder.

18. The manipulating handle for cardiac implant according to claim 17, wherein a rear clip assembly position indicating rod is connected to a rear portion of the outer tube connecting seat, a front clip assembly position indicating rod is connected to a front portion of the stroke seat, and an observation window for observing the relative positions of the rear clip assembly position indicating rod and the front clip assembly position indicating rod is provided on the housing, the observation window being located between the outer tube connecting seat and the stroke seat.

19. An implanting instrument for a cardiac implant, comprising a delivery sheath for carrying the implant and an operating handle for controlling the delivery sheath, the delivery sheath comprising an outer tube, a middle tube and an inner tube which are laminated from inside to outside, wherein the operating handle is the operating handle for the cardiac implant according to any one of claims 1 to 18.

20. A method of operating an operating handle for a cardiac implant, comprising the steps of:

after the front clamp assembly and the rear clamp assembly of the implant are combined, the middle pipe connecting seat of the operating handle moves backwards for a first stroke until the middle pipe connecting seat is blocked by the first locking piece, so that the front clamp assembly is closed to the minimum;

the inner tube connecting assembly of the operating handle is moved backwards to release the implant.

21. The method of claim 20, wherein removing the first locking member is preceded by:

the separation knob of the operating handle is rotated along the first direction and moves backwards to make room for a second locking piece which is propped against the rear side of the middle pipe connecting seat;

then, the first operating knob of the operating handle is rotated to enable the middle pipe connecting seat to move backwards for the second stroke.

22. The operating method according to claim 21, wherein the middle pipe joint seat moves backwards by the second stroke and then rebounds to the first stroke to withdraw the connecting part of the middle pipe joint seat from the inner pipe connecting assembly.

23. The method of claim 21, wherein the step of moving the inner tube connection assembly of the operating handle backward comprises:

24. Operating method according to claim 20, characterized in that an operating handle of a cardiac implant according to any one of claims 1 to 18 is used, which operating method is embodied as follows:

s1, opening the front clamp assembly by rotating a first operating knob, opening the rear clamp assembly by operating an operating rod, and combining the front clamp assembly and the rear clamp assembly by rotating a second operating knob and a third operating knob to control a stroke seat and an outer pipe connecting seat to move;

s3, removing the first locking piece;